Apparatus and method for treatment of dry eye using radio frequency heating

ABSTRACT

The present disclosure is related to a treatment probe and method for treating dry eye. The treatment probe may include a thin stainless steel tip, a spacer to ensure proper contact and protect the skin of a patient, a sensor to provide temperature feedback to the power supply providing RF energy to the treatment probe. The treatment focuses on a patient&#39;s temple and periorbital area.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 120 of U.S. patentapplication Ser. No. 15/094,814, filed on Apr. 8, 2016, which is beingconverted to a U.S. Provisional Application.

FIELD OF THE DISCLOSURE

The present disclosure relates to systems and methods for treatment ofevaporative dry eye by radio-frequency heating and reduction toperiorbital skin laxity.

BACKGROUND

Meibomian Gland Dysfunction (MGD) can be the result of capped glands,plugged or non-functioning glands or partial or complete gland atrophy.Studies have demonstrated that up to 86% of Dry Eye Syndrome conditions(also known as keratoconjunctivitis sicca and keratitis sicca) are dueto evaporative issues connected with MGD. As a result, more emphasis isbeing placed on MGD treatment for Dry Eye. Current treatments includeLipiFlow from Tear Science, MiBo ThermoFlo from Pain Point Medical, hotpacks and lid scrubs (commercial to home treatment), yet all of thesetherapies have drawbacks.

LipiFlow has been proven to work well, but it is expensive withtreatments costing over $1800. The functioning unit of the LipiFlow(heating/massaging units) is not intended for reuse. The advantage ofLipiFlow is that it massages the lid from the exterior dermal side whileheat is simultaneously applied transconjunctivally, making it aneffective and efficient treatment. MiBo ThermoFlo applies heattranscutaneously, which is less efficient in terms of altering theconsistency of meibomian lipids.

Other methods designed to deliver heat to the lids are appliedsuperficially, e.g., masks, hot washcloths, and others, and have provento be inadequate for a number of reasons, most specifically due to theirinability to bring gland temperature up to required levels, which isestimated to be 40-43° C. (104-109° F.).

ThermiEye™ technology is currently used on the market as a cosmetic skintreatment to tighten skin and reduce wrinkles, under the trade nameThermiSmooth™. It has been shown to be well tolerated and safe forcosmetic use, but has not been considered for treatment of dry eye untilnow.

This background information is provided to reveal information believedby the applicant to be of possible relevance to the present disclosure.No admission is intended, nor should be construed, that any of thepreceding information constitutes prior art against the presentdisclosure.

SUMMARY OF THE DISCLOSURE

With the above in mind, embodiments of the present disclosure arerelated to a treatment probe and method for treating dry eye using an RFelectrode assembly coupled to the treatment tip, wherein the electrodecoupled to the treatment tip is configured to transfer radiofrequencyenergy to the skin surrounding the eye in such a way that nerve tissueis stimulated and/or strengthened around the eye, reducing MGD.Optionally, a temperature measuring feature is coupled to the electrodeassembly, wherein the temperature—measuring feature coupled to theelectrode assembly is configured to monitor and regulate electrode andskin temperature, and a protective element that helps to ensure goodcontact between the electrode and the patient's skin as the electrode ismoved across a patient's face.

The ThermiEye™ system delivers radiofrequency energy deep into the skincausing heat to build up where the skin and fat layer meet. The heatescalates to about 42°-45° C., improve Meibomian gland function bystimulating nerve tissue. Additionally, since evaporative dry eye mayalso be impacted by poor lid-globe apposition, the reduction of tissuelaxity and improved elasticity of the tissue surrounding the eye lid mayhelp to further diminish those signs and symptoms classically associatedwith dry eye.

In various embodiments, the disclosed protocol treats periorbital skinlaxity and evaporative dry eye conditions associated with MGD.

In one embodiment, the present disclosure is directed to a method oftreatment for dry eye (Method 1), the method comprising directing aradiofrequency energy to target tissue surrounding the eye in an amountsufficient to stimulate but not damage nerve tissue.

1.1 Method 1, wherein the radiofrequency energy is applied through aprobe having at least one electrode surface that emits radiofrequencyenergy.

1.2 Method 1 or 1.1, wherein the radiofrequency energy applied to is lowfrequency.

1.3 Method 1 or 1.1-1.2, wherein the radiofrequency energy is emitted ata range of about 400 kHz to about 520 kHz; about 430 kHz to about 490kHz; about 450 kHz to about 470 kHz; about 455 kHz to about 465 kHz; orabout 460 kHz.

1.4 Method 1 or 1.1-1.3, wherein the radiofrequency energy is applied inan amount necessary to stimulate nerves to induce secretion of one ormore Meibomian glands.

1.5 Method 1 or 1.1-1.4, wherein the radiofrequency energy is appliedfor a period of time and at a level necessary to raise the surfacetemperature of target tissue (i.e., epidermis directly above treateddermal tissue) to a temperature between 35 to 47 degrees Celsius.

1.6 Method 1 or 1.1-1.5, wherein the radiofrequency energy is appliedfor a period of time and at a frequency necessary to raise the surfacetemperature of target tissue (i.e., epidermis directly above treateddermal tissue) to a temperature between 38 to 45 degrees Celsius.

1.7 Method 1 or 1.1-1.6, wherein the radiofrequency energy is appliedfor a period of time and at a frequency necessary to raise the surfacetemperature of target tissue (i.e., epidermis directly above treateddermal tissue) to a temperature between 42 to 44 degrees Celsius.

1.8 Method 1 or 1.4-1.7, wherein the target tissue is heated at between1 and 5 mm beneath the surface (i.e., between 2 and 2.5 mm beneath thesurface).

1.9 Method 1 or 1.1-1.8, wherein the method further comprises applyingan electrically conductive gel at the site of the target tissue on apatient.

1.10 Method 1 or 1.1-1.9, wherein the radiofrequency energy is appliedto the temple and/or to periorbital tissue adjacent to the eye and/oreyelid.

1.11 Method 1 or 1.1-1.10, wherein the radiofrequency energy is appliedto the temple and then is applied to the periorbital tissue adjacent tothe eye and/or eyelid.

1.12 Method 1 or 1.1-1.11, wherein the radiofrequency energy is appliedfor a period of 15 seconds to 20 minutes, a period of 8 minutes to 15minutes; a period of 8 minutes to 10 minutes; a period of 10 minutes to12 minutes; or a period of 12 to 15 minutes.

1.13 Method 1 or 1.1-1.12, wherein the radiofrequency energy is notapplied to the eyelid.

1.14 Method 1 or 1.1-1.13, further comprising contacting a grounding padto a patient on an area of the skin removed from the tissue surroundingthe eye.

1.15 Method 1 or 1.1-1.14, wherein the radiofrequency energy is appliedusing a probe that comprises:

a. an electrically conductive treatment tip positioned at the distal endof a handle,

b. a cable in contact with the treatment tip and running from the distalend of the handle to the proximal end of the handle, the cable extendingfrom the handle to a power supply providing radio-frequency energy tothe tip through the cord, wherein the cord is removable from the powersupply

c. a spacer configured to provide an electrically conductive barrierbetween the treatment tip and a patient's skin, wherein the treatmenttip is adapted to accept the spacer.

1.16 Method 1.15, wherein the cable is permanently affixed within thehandle.

1.17 Method 1.15-1.16, wherein the treatment tip comprises a flat distalend configured to contact a patient's skin.

1.18 Method 1.15-1.17, wherein the treatment tip comprises anelectrically conductive circumferential sidewall.

1.19 Method 1.18, wherein the electrically conductive circumferentialsidewall is continuous with the flat distal end of the treatment tip.

1.20 Method 1.15-1.19, wherein the spacer is shaped to cover the entiretreatment tip.

1.21 Method 1.20-1.20, wherein the spacer is shaped to cover the flatdistal end and circumferential sidewall of the treatment tip.

1.22 Method 1.15-1.21, wherein the handle comprises an electricallyinsulative material.

1.23 Method 1.15-1.22, further comprising a temperature sensor (i.e., athermocouple).

1.24 Method 1.23, wherein the temperature sensor is positioned adjacentthe treatment tip.

1.25 Method 1.23-1.24, wherein the temperature sensor abuts an innersurface of the treatment tip.

1.26 Method 1.23-1.24, wherein the temperature sensor is positioned atan outer surface of the treatment tip to facilitate contact with apatient's skin.

1.27 Method 1.15-1.26, wherein the treatment tip has a thickness ofabout 100 microns.

1.28 Method 1.15-1.27, wherein the treatment tip is between 10 mm and 20mm wide.

In another embodiment, the present disclosure is directed toradio-frequency emitter (Emitter 2) comprising:

a. an electrically conductive treatment tip positioned at the distal endof a handle,

b. a cable in contact with the treatment tip and running from the distalend of the handle to the proximal end of the handle, the cable extendingfrom the handle to a power supply providing radio-frequency energy tothe tip through the cord, wherein the cord is removable from the powersupply

c. a spacer configured to provide an electrically conductive barrierbetween the treatment tip and a patient's skin, wherein the treatmenttip is adapted to accept the spacer.

2.1 Emitter 2, wherein the cable is permanently affixed within thehandle.

2.2 Emitter 2 or 2.1, wherein the treatment tip comprises a flat distalend configured to contact a patient's skin.

2.3 Emitter 2 or 2.1-2.2, wherein the treatment tip comprises anelectrically conductive circumferential sidewall.

2.4 Emitter 2.3, wherein the electrically conductive circumferentialsidewall is continuous with the flat distal end of the treatment tip.

2.5 Emitter 2 or 2.1-2.4, wherein the spacer is shaped to cover theentire treatment tip.

2.6 Emitter 2 or 2.1-2.5, wherein the spacer is shaped to cover the flatdistal end and circumferential sidewall of the treatment tip.

2.7 Emitter 2 or 2.1-2.6, wherein the handle comprises an electricallyinsulative material.

2.8 Emitter 2 or 2.1-2.7, further comprising a temperature sensor (i.e.,a thermocouple).

2.9 Emitter 2.8, wherein the temperature sensor is positioned adjacentthe treatment tip.

2.10 Emitter 2.8-2.9, wherein the temperature sensor abuts an innersurface of the treatment tip.

2.11 Emitter 2.8-2.9, wherein the temperature sensor is positioned at anouter surface of the treatment tip to facilitate contact with apatient's skin.

2.12 Emitter 2 or 2.1-2.11, wherein the treatment tip has a thickness ofabout 100 microns.

2.13 Emitter 2 or 2.1-2.12, wherein the treatment tip is between 10 mmto 20 mm wide.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an orthogonal view of the user end of an RFE10D Apparatus.

FIG. 2 is an orthogonal view of the connection end of an RFE10DApparatus.

FIG. 3 is a section view of the Apparatus tip as shown in Section A ofFIG. 1.

FIG. 4 is a section view the Apparatus tip as shown in Section A of FIG.1 with an optional electrode construction.

FIG. 5 is a flow chart of the method of treatment.

FIG. 6 shows one possible pattern of treatment.

FIG. 7 shows one embodiment of the physical instruments making up theapparatus of the disclosure.

DETAILED DESCRIPTION

The present disclosure will now be described more fully hereinafter withreference to the accompanying drawings, in which preferred embodimentsof the disclosure are shown. This disclosure may, however, be embodiedin many different forms and should not be construed as limited to theembodiments set forth herein. Rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the disclosure to those skilled in the art. Those ofordinary skill in the art realize that the following descriptions of theembodiments of the present disclosure are illustrative and are notintended to be limiting in any way. Other embodiments of the presentdisclosure will readily suggest themselves to such skilled personshaving the benefit of this disclosure. Like numbers refer to likeelements throughout.

Although the following detailed description contains many specifics forthe purposes of illustration, anyone of ordinary skill in the art willappreciate that many variations and alterations to the following detailsare within the scope of the disclosure. Accordingly, the followingembodiments of the disclosure are set forth without any loss ofgenerality to, and without imposing limitations upon, the claimeddisclosure.

In this detailed description of the present disclosure, a person skilledin the art should note that directional terms, such as “above,” “below,”“upper,” “lower,” and other like terms are used for the convenience ofthe reader in reference to the drawings. Also, a person skilled in theart should notice this description may contain other terminology toconvey position, orientation, and direction without departing from theprinciples of the present disclosure.

Furthermore, in this detailed description, a person skilled in the artshould note that quantitative qualifying terms such as “generally,”“substantially, “mostly,” and other terms are used, in general, to meanthat the referred to object, characteristic, or quality constitutes amajority of the subject of the reference. The meaning of any of theseterms is dependent upon the context within which it is used, and themeaning may be expressly modified.

Referring now to FIGS. 1-3, a device, according to an embodiment of thepresent disclosure disclosed is an RFE-10D RF Electrode Assembly,comprising a Handle 1 with an electrode Tip 3 on it that transfers radiofrequency energy into the target tissue only at the location the Tipcontacts the tissue. The device receives its the radio frequency energythrough a Cable 2 affixed to a Radio Frequency Generator 20 (not shownin FIG. 3). The radio frequency energy travels thru the tissue and exitsthe body where a large Return Pad 30 is affixed to the patient (shown inFIG. 7).

The treatment probe may be configured to elevate the eye'stransconjunctival tissue temperatures to about 40-45° C. to promotetissue contracture.

Tip 3 must contact the tissue, but as shown in FIG. 4A, an optionalSpacer 9 composed of a soft, electrically-conductive material may beemployed to provide good electrode-patient contact. Use of Spacer 9helps to ensure the radio frequency energy is evenly distributed overthe intended surface area of treatment. Though Spacer 9 shown in FIG. 4Ahas a particular shape, the electrode could be flat, convex, concave, orother shapes that may be appropriate and comfortable in practice.

The optional Sensor 10 may be any type of thermal sensing device,including but not limited to a thermocouple made part of Spacer 9, inwhich case Sensor 10 is affixed to the Spacer 9 or Tip 3 so it contactsthe patient's skin, or an optical thermal sensing system mounted on theSpacer 9 or Tip 3 that does not make contact, but reads the temperatureof the patient's skin. The disclosure is not limited to any particularapproach to measuring the skin of the patient. The current embodiment ofthe disclosure employs a very thin walled cup with the thermometer toits inside wall.

FIG. 7 shows the Emitter is powered by a Power Source 20 conducive toproviding energy to the Emitter through the Connector 8 and Cable 2.

The disclosed Emitter is used to treat the patient around the eye andforehead, using the process disclosed in FIGS. 5 and 6.

In one embodiment, a Control Unit 20 may be configured to deliveradditional RF energy so that the temperature at the Sensor 10 can bekept at a desired temperature by the Control Unit's monitoring of theSensor 10 and applying more or less power to the Emitter.

One of ordinary skill in the art will recognize that there are variousalgorithms for feedback circuits and each may be used by the ControlUnit 20 to accomplish substantially the same result described in theembodiment above. One of ordinary skill in the art will also recognizethat a plurality of methods exist to provide energy through heat. Inanother embodiment of the present disclosure, the RF energy may bereplaced with ultrasound, laser heating, and other methods of providingenergy through heat.

Referring now to FIG. 4, the Emitter can be constructed to accept anoptional Spacer 9. Spacer 9 can be constructed to use an adhesive or anynumber of other methods to be placed on Tip 3. When installed on Tip 3,a user can easily maintain an optimal distance between the Emitter andthe patient's skin. Spacer 9 can be washable or disposable, providingeasy sanitary practices and separation between patients by changingSpacers 9 between them.

In the disclosed procedure, a user treats the patient's face asindicated in FIGS. 5 and 6. The effect of this treatment is to stimulatenerve growth surrounding the eye, which reduces MGD conditions in thepatient.

To accomplish this task most effectively, the nervous tissue around theeye is stimulated by RF energy that traverses a tissue bed. As electriccurrent permeates a tissue layer, ions found within that tissue layerconduct the electric current, increasing kinetic activity of the ionswithin. Increased ion kinetics and oscillations engender resistivetissue thermogenesis. Thermogenesis may be calculable via the SpecificAbsorption Rate (hereinafter referred to as “SAR”) equation. SARassesses local electrical conductivity and magnitude of local electriccurrent density generated around an electrode.

A therapeutic benefit of the heat may be localized thermogenesis. Anelectric field strength generated by the RF energy may be capable ofheating tissue in close proximity to the Emitter. With proper powercontrols, a generated ideal thermal endpoint may occur close to theEmitter. As a result, only the desired specific tissue may be affected.

In some embodiments, the radiofrequency probe disclosed herein is usedin a method of stimulating or innervating nerve tissue to treat dry eye(i.e., activate one or more Meibomian glands in a patient).

A medical practitioner or qualified user then powers on power source 20so as to provide radio frequency energy to treatment tip 3 of the probe.The treatment probe is configured to apply radiofrequency energy to thetreatment area of a patient's skin to raise the temperature of thetissue. The radiofrequency energy is applied in an amount necessary tostimulate nerves to induce secretion of one or more Meibomian glands.Notably, the radiofrequency emitted from treatment tip 3 is generally alow frequency, which is intended to provide an amount of energy to thetreatment area to specifically stimulate or innervate nerve tissuewithout damaging surrounding tissue. In various embodiments, theradiofrequency energy emitted has a frequency range of about 400 kHz toabout 520 kHz; about 430 kHz to about 490 kHz; about 450 kHz to about470 kHz; about 455 kHz to about 465 kHz; or about 460 kHz. Applicationof the radiofrequency energy according to the present method raises thetemperature of the target area on a patient's skin from 35° C. to 47° C.In some embodiments, the temperature is raised from 38° C. to a maximumtemperature of 42° C. to 45° C. The application of radiofrequency energyto the treatment area on a patient results in dermal tissue heated at adepth of about 1 mm to about 5 mm beneath the outer layer of theepidermis, preferably between 2 mm and 2.5 mm beneath said outer layerof the epidermis.

A medical practitioner may adjust the desired target temperature asnecessary according to the needs of the patient. In various embodiments,the probe comprises a temperature sensor 10, which is configured toprovide temperature information feedback to power source 20. Asdiscussed herein, in various embodiments power source 20 containsprogramming logic to automatically cease supply of radiofrequency energyonce temperature sensor 10 indicates that a target temperature has beenreached. Thus, in methods of use, a medical practitioner may set atarget temperature in power source 20, such that during use, uponreaching the target temperature, power source 20 automatically ceases toprovide radiofrequency energy to treatment tip 3.

Once a target temperature is set, a medical practitioner bringstreatment tip 3 in contact with the temple and/or periorbital tissuesurrounding the eye. The probe is oriented relative to the targetsurface such that the entire surface of the flat distal end of treatmenttip 3 is substantially parallel with the patient's skin. An evenpressure is applied while moving the treatment tip around the targetarea at the patient's temple and/or periorbital tissue. This motion isrepeated until the target skin temperature is reached. In variousembodiments, treatment tip 3 is applied to an area of the patient's skinwhere nerves in communication with Meibomian glands are located. Theradiofrequency energy is applied at such a level and for a period oftime so as to stimulate or innervate the nerves involved in Meibomiangland function. While radiofrequency energy may be applied to theperiorbital tissue around the eye, it is not applied to the eyelid.

In some embodiments, the treatment area comprises a “C” shape around apatient's eye. The treatment area is continuous from the superior nasalareas located slightly below the eyebrow to the temporal area to thetissue beneath the lower eyelid. In various embodiments, theradiofrequency energy is applied for a period of 15 seconds to 20minutes, and may be adjusted according to the needs of a particularpatient. Thus, in some embodiments, the treatment spans a period of 8minutes to 15 minutes; a period of 8 minutes to 10 minutes; a period of10 minutes to 12 minutes; or a period of 12 to 15 minutes.

Generally, the methods of treatment as disclosed herein compriseapplying a grounding pad 30 to an area of the patient's skin close tothe area being treated. In various embodiments, the area being treatedis the periorbital tissue surrounding the eye and/or temple area on apatient's skin. Grounding pad 30 may be disposable and comprise anadhesive surface to adhere to a selected area of the patient's skin. Anelectrically conductive gel (i.e., coupling gel) is applied to thetreatment area of the patient prior to treatment tip 3 being broughtinto contact with the treatment area. In some embodiments, the gel is anaqueous gel that does not contain glycerin. Preferably, the gel iscolorless.

In this Emitter, the Tip 3 has been made much thinner, with embodimentsranging from 10 to 20 mm in width, but only 100 micron thick. Thisconstruction is advantageous because it allows for quick response time.

Regulation of tissue temperature may derive from power control circuitryresiding in the Power Source 2 0, which controls the RF power output(and heating) by increasing or decreasing the RF voltage that istransmitted through the cable and to the Tip into the tissue, andmonitoring patient tissue temperature.

Some of the illustrative aspects of the present. Disclosure may beadvantageous in solving the problems herein described and other problemsnot discussed which are discoverable by a skilled artisan. While theabove description contains much specificity, these should not beconstrued as limitations on the scope of any embodiment, but asexemplifications of the presented embodiments thereof. Many otherramifications and variations are possible within the teachings of thevarious embodiments. While the disclosure has been described withreference to exemplary embodiments, it will be understood by thoseskilled in the art that various changes may be made and equivalents maybe substituted for elements thereof without departing from the scope ofthe disclosure. In addition, many modifications may be made to adapt aparticular situation or material to the teachings of the disclosurewithout departing from the essential scope thereof. Therefore, it isintended that the disclosure not be limited to the particular embodimentdisclosed as the best or only mode contemplated for carrying out thisdisclosure, but that the disclosure will include all embodiments fallingwithin the scope of the appended claims. Also, the drawings and thedescription, there have been disclosed exemplary embodiments of thedisclosure and, although specific terms may have been employed, they areunless otherwise stated used in a generic and descriptive sense only andnot for purposes of limitation, the scope of the disclosure thereforenot being so limited. Moreover, the use of the terms first, second, etc.do not denote any order or importance, but rather the terms first,second, etc. are used to distinguish one element from another.Furthermore, the use of the terms a, an, etc. do not denote a limitationof quantity, but rather denote the presence of at least one of thereferenced item.

Thus, the scope of the disclosure should be determined by the appendedclaims and their legal equivalents, and not by the examples given.

A legend of the components discussed in the application and shown on thedrawings is as follows:

-   -   1 Handle    -   2 Cable (Silicon Jacket)    -   3 Tip, 10 mm    -   5 Bend Relief    -   6 Heat Shrink Label Band    -   7 Bend Relief    -   8 Connector    -   9 Spacer (optional)    -   10 Sensor    -   20 Power Source (Radio-Frequency Generator)    -   30 Return Pad

EXAMPLES Example 1

18 patients aged 45 to 65 with evaporative dry eye and periorbital skinlaxity were selected to undergo radiofrequency treatment for dry eye.All selected patients exhibited Meibomian gland dropout. The enrolledpatients were evaluated and baseline measures for periorbital skinlaxity, presence of wrinkles, dry eye symptoms, ocular surface andextent of Meibomian gland dropout. After the initial evaluation,patients were treated in a randomized eye. Contralateral eyes were leftuntreated.

Prior to each instance of treatment, patients were given questionnairesto evaluate their apparent symptoms. During treatment, a grounding padwas applied to an area on the skin close to the treatment area (i.e.,periorbital tissue). Conduction gel was applied to the skin such thatthe treatment area was thoroughly coated. The RF generator was poweredup, and the treatment temperature was initially set to 38° C. Theelectrode on the probe was brought into full contact with the patient'sskin, and using even pressure and sweeping motions, the temperature ofthe skin was increased to the target temperature setting (i.e., 38° C.).Once achieved, the temperature was raised by increments of one degreeuntil a target temperature of 42° C. to 45° C. was reached. Aftertreatment, all patients were cleansed and were tested for tear meniscusheight, standard dry eye test (DET) using sodium fluorescein strips fortear film break-up time (TFBUT), non-invasive tear break-up time(NITBUT), lipid layer thickness (LLT), and corneal staining.

Treatment according to the method carried out on day 0 was repeated tothe randomized eye on days 15 and 30 of the study, and observations wererecorded. The contralateral eye was again left untreated. On day 45, notreatment was given, but exit observations were recorded.

A comparison of measures between Visit 1 and the Exit visit on Day 45showed that the vast majority of patients noticed an improvement in dryeye symptoms over the course of the test period. 9 of the 18 patientsshowed some incremental improvements with DET TFBUT and 12 of the 18patients showed improvement in corneal staining. 9 patients demonstratedimprovements in LLT, and 10 patients improved with NITBUT, which wasmeasured using a keratograph. These results are especially encouragingsince the treatment was not applied to the eye lid at or near theMeibomian glands, but rather on the surrounding tissue removed from theMeibomian glands. There were no noticeable changes to tear meniscusheight or Meibomian glands over the course of the study.

Interestingly, the untreated contralateral eyes showed almost equivalentimprovements in the same four objective measures LLT, corneal staining,NIBUT and DET TFBUT. This effect was especially unexpected, since noradiofrequency treatment was not applied locally to contralateraltissue.

The results show significant improvement in dry eye symptoms using thedescribed treatment.

We claim:
 1. A method of treatment for dry eye, the method comprisingapplication of a radiofrequency energy to target tissue surrounding theeye in an amount sufficient to stimulate but not damage nerve tissue. 2.A method according to claim 1, wherein the radiofrequency energy isapplied through a probe having at least one electrode surface that emitsradiofrequency energy.
 3. A method according to claim 1, wherein theradiofrequency energy applied to is low frequency.
 4. A method accordingto claim 1, wherein the radiofrequency energy is emitted at a range ofabout 400 kHz to about 520 kHz; about 430 kHz to about 490 kHz; about450 kHz to about 470 kHz; about 455 kHz to about 465 kHz; or about 460kHz.
 5. A method according to claim 1, wherein the radiofrequency energyis applied in an amount necessary to stimulate nerves to inducesecretion of one or more Meibomian glands.
 6. A method according toclaim 1, wherein the radiofrequency energy is applied for a period oftime and at a level necessary to raise the surface temperature of thetarget tissue to a temperature between 35 to 47 degrees Celsius.
 7. Amethod according to claim 6, wherein the radiofrequency energy isapplied for a period of time and at a frequency necessary to raise thesurface temperature of the target tissue to a temperature between 38 to45 degrees Celsius.
 8. A method according to claim 7, wherein theradiofrequency energy is applied for a period of time and at a frequencynecessary to raise the surface temperature of the target tissue to atemperature between 42 to 44 degrees Celsius.
 9. A method according toclaim 1, wherein the target tissue is heated at between 1 and 5 mmbeneath the surface (i.e., between 2 and 2.5 mm beneath the surface).10. A method according to claim 9, wherein the method further comprisesapplying an electrically conductive gel at the site of the target tissueon a patient.
 11. A method according to claim 1, wherein theradiofrequency energy is applied to the temple and/or to periorbitaltissue adjacent to the eye and/or eyelid.
 12. A method according toclaim 11, wherein the radiofrequency energy is applied to the temple andthen is applied to the periorbital tissue adjacent to the eye and/oreyelid.
 13. A method according to claim 1, wherein the radiofrequencyenergy is applied for a period of 15 seconds to 20 minutes, a period of8 minutes to 15 minutes; a period of 8 minutes to 10 minutes; a periodof 10 minutes to 12 minutes; or a period of 12 to 15 minutes.
 14. Amethod according to claim 1, wherein the radiofrequency energy is notapplied to the eyelid.
 15. A method according to claim 1, furthercomprising contacting a grounding pad to a patient on an area of theskin removed from the tissue surrounding the eye.
 16. A method accordingto claim 1, wherein the radiofrequency energy is applied using a probethat comprises: a. an electrically conductive treatment tip positionedat the distal end of a handle, b. a cable in contact with the treatmenttip and running from the distal end of the handle to the proximal end ofthe handle, the cable extending from the handle to a power supplyproviding radio-frequency energy to the tip through the cord, whereinthe cord is removable from the power supply c. a spacer configured toprovide an electrically conductive barrier between the treatment tip anda patient's skin, wherein the treatment tip is adapted to accept thespacer.